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Animal Assisted Activities on the Stress and Social Anxiety

Primary Purpose

Stress, Social Anxiety, Disabling Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Animal Assisted Activity Program
Sponsored by
Şeyma Demiralay
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress focused on measuring pet therapy, disabled child, stress, social anxiety

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Volunteering to participate in research
  • Being in the age range of 8-11,
  • Only being physically disabled,
  • Reading and writing,
  • Parent's consent for the child to participate in the study

Exclusion Criteria:

  • Do not have an obstacle about the message
  • Being in any chronic disease with immune deficiency,
  • Don't have any animal allergies,
  • Application being afraid of animals,
  • Have an existing animal of your own, past or present

Extraction Criteria:

  • Not participating in the interview for more than 2 weeks,
  • Development of a medical condition that prevents communication,
  • Participant's right to withdraw from the research in line with his family or his own request

Sites / Locations

  • Şeyma Demiralay

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Control group

Arm Description

The Effect Of Animal Assisted Activities On The Stress And Social Anxiety Levels Of Disabled Children Animal Assisted Activity Program (HayDAP)

No intervention

Outcomes

Primary Outcome Measures

Stress
Perceived Stress Levell Scale; This one-dimensional scale consists of 9 items. It has a 4-point Likert type rating. The scores that can be obtained from the scale are between 9 and 36. The high scores on the scale questions indicate that the individual's stress level is means to be high.

Secondary Outcome Measures

Social Anxiety
Social Anxiety Scale for Children-Revised; This one-dimensional scale has a 5-point Likert-type scale consisting of 18 items. The scores that can be obtained from the scale are between 18 and 90. The higher the score, the higher the social anxiety level.
Blood Pressure
Blodd Pressure

Full Information

First Posted
January 19, 2021
Last Updated
April 16, 2021
Sponsor
Şeyma Demiralay
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1. Study Identification

Unique Protocol Identification Number
NCT04845100
Brief Title
Animal Assisted Activities on the Stress and Social Anxiety
Official Title
The Effect of Animal Assisted Activities on the Stress and Social Anxiety Levels of Disabled Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
November 15, 2020 (Actual)
Study Completion Date
November 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Şeyma Demiralay

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ABSTRACT Objective: The aim of the study is to determine the effects of animal-assisted activities on the stress and social anxiety levels of physically disabled children. Method: The research was carried out in two separate Special Education and Rehabilitation Centers providing education under the Antalya Provincial Directorate of National Education. The data of the study were obtained between November 2019-September 2020. The study is a single blind randomized controlled study designed in a pretest, posttest and follow-up design. The study was carried out in two different institutions to prevent contamination. Institutions are determined by an independent lottery method. The sample of the study consisted of 44 physically disabled children between the ages of 8-11, as the intervention group (n: 21) and the control group (n: 23). A 45-60 minute structured animal supported activity program (HayDAP) was applied to the intervention group, once a week for 7 weeks. Interviews were conducted individually. The data of the study were obtained using Personal Information Form (KBF), Perceived Stress Scale (PSS) and Social Anxiety Scale for Children. Follow-up evaluation was made at the end of the 1st month following the completion of the application. There was no intervention in the control group. The data were analyzed using the Pearson Ki-Square Test in SPSS 23.0 package program, Fisher's Exact Test if large, Shapiro-Wilks Test, Box M, Bonferroni and mixed pattern ANOVA tests. A 95% significance level (or α = 0.05 margin of error) was used to determine the differences in the analyzes.
Detailed Description
ANIMAL ASSISTED ACTIVITY PROGRAM (HayDAP): st week (Pre-test, introduction-introduction) Goal. Developing a trusting relationship nd week (Information about cats) Purpose: To strengthen the bond that develops between the child and the application animal th (Cat story reading) Purpose: To evaluate the emotions and solutions in the face of stressful life events in the face of the story. th week (Teaching songs, poems, rhymes about cat) Objective: To determine the factors that may cause social anxiety and to support the increase of self-confidence in the child. th week (Making / decorating a cat house) Purpose: Discussing the roles and relationships of the child in his / her social environment and developing awareness with examples of cats. Improving communication and problem solving skills th week (Participation in the rehabilitation program with the treatment animal) Purpose: To monitor the child's adherence to treatment Evaluating the child's compliance with the treatment during physiotherapy activities while being observed by the application cat and the practitioner th week (Evaluation and closing, last test) Purpose: Finishing the whole process by passing A healthy termination of the bond formed with the practice cat

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Social Anxiety, Disabling Disease, Animal Communication, Nursing Caries, Child
Keywords
pet therapy, disabled child, stress, social anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a single blind randomized controlled study designed in a pretest, posttest and follow-up design.
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The Effect Of Animal Assisted Activities On The Stress And Social Anxiety Levels Of Disabled Children Animal Assisted Activity Program (HayDAP)
Arm Title
Control group
Arm Type
Other
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Animal Assisted Activity Program
Intervention Description
Animal Assisted Activity Program (HayDAP) st week (Pre-test, introduction-introduction) nd week (Information about cats) th (Cat story reading) th week (Teaching songs, poems, rhymes about cat) th week (Making / decorating a cat house) th week (Participation in the rehabilitation program with the treatment animal) th week (Evaluation and closing, last test)
Primary Outcome Measure Information:
Title
Stress
Description
Perceived Stress Levell Scale; This one-dimensional scale consists of 9 items. It has a 4-point Likert type rating. The scores that can be obtained from the scale are between 9 and 36. The high scores on the scale questions indicate that the individual's stress level is means to be high.
Time Frame
7 Weeks, 1 Month
Secondary Outcome Measure Information:
Title
Social Anxiety
Description
Social Anxiety Scale for Children-Revised; This one-dimensional scale has a 5-point Likert-type scale consisting of 18 items. The scores that can be obtained from the scale are between 18 and 90. The higher the score, the higher the social anxiety level.
Time Frame
7 Weeks, 1 Month
Title
Blood Pressure
Description
Blodd Pressure
Time Frame
Only intervention group, every pre-intervention and post-intervention: During HayDAP intervention, for 7 weeks, before and after each application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Volunteering to participate in research Being in the age range of 8-11, Only being physically disabled, Reading and writing, Parent's consent for the child to participate in the study Exclusion Criteria: Do not have an obstacle about the message Being in any chronic disease with immune deficiency, Don't have any animal allergies, Application being afraid of animals, Have an existing animal of your own, past or present Extraction Criteria: Not participating in the interview for more than 2 weeks, Development of a medical condition that prevents communication, Participant's right to withdraw from the research in line with his family or his own request
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İlkay KESER, Ass. Prof.
Organizational Affiliation
Akdeniz University
Official's Role
Study Director
Facility Information:
Facility Name
Şeyma Demiralay
City
Antalya
ZIP/Postal Code
07210
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Animal Assisted Activity Program (HayDAP) st week (Pre-test, introduction-introduction) nd week (Information about cats) th (Cat story reading) th week (Teaching songs, poems, rhymes about cat) th week (Making / decorating a cat house) th week (Participation in the rehabilitation program with the treatment animal) th week (Evaluation and closing, last test)

Learn more about this trial

Animal Assisted Activities on the Stress and Social Anxiety

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